FDA Inspection
SnugZ USA, Inc.SnugZ USA, Inc. – FDA Inspection, Nov 30, 2018
Record Details
This FDA Inspection record concerns SnugZ USA, Inc., with an inspection on November 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7f048a76-aa86-4f8a-a649-bab1958b89bb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1073275
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 14 citations.
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Other FDA inspections of SnugZ USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2026 | Not classified | Denver District Office | Drug Quality Assurance |
| July 8, 2025 | Not classified | Denver District Office | |
| September 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SnugZ USA, Inc.
- FDA Inspection 1315042 - 2026-05-01
- FDA Inspection 1277549 - 2025-07-08
- FDA Inspection 1151943 - 2021-09-17
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